Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation

NCT03479320 | Completed Phase 4

• 1 other identifier: IRC/1078/017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized double blinded clinical study conducted in patients undergoing oral and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery.Normal saline group will receive same amount of intravenous normal saline .The primary outcome will be postoperative pain using the NRS scale during first 24 hours and time to first analgesic request

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Postoperative Numeric Rating Scale(NRS)

  Pain at rest and with cough or movement using the NRS scale, which ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain

  24 hours

Secondary Outcomes (3)

• Total opioid consumption

  24 hours

• Time to first analgesic request

  24 hours

• Side effects

  24 hours

Study Arms (2)

Lidocaine group

EXPERIMENTAL

Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

They will receive the same volume of 0.9% of normal saline as calculated for the experimental group

Drug: Placebo

Interventions

Lidocaine DRUG

Postoperative analgesic effects will be compared between lidocaine and normal saline group

Lidocaine group

Placebo DRUG

Postoperative anlagesic requirements will be calculated and compared with experimental group

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients 18-60 years of age
• Patients of ASA (American Society of Anesthesiologists) Class I or Class II (I- healthy with no systemic disease, II- mild systemic disease with no functional limitation) who require oral and maxillofacial surgeries under general anesthesia

You may not qualify if:

• Refusal to give consent.
• Hypersensitivity or allergy to the study medication.
• ASA physical status III or more.
• Subjects with known severe hepatic or renal dysfunction or cardiac dysrhythmia or atrioventricular block.
• History of taking opioids or antiarrhythmic drugs within 1 week of surgery.
• History of drug or alcohol abuse
• History of psychiatric disorders.
• Patients requiring emergency surgery.
• Patients unable to comprehend pain assessment

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

B. P. Koirala Institute of Health Sciences

Dharān, 34464, Nepal

Location

Related Publications (1)

• Mahato VK, Dongol A, Acharya P, Yadav AK, Subedi A, Jaisani MR. "Can Perioperative Intravenous Lidocaine Decrease Postoperative Pain After Oral and Maxillofacial Surgeries?": A Randomized Clinical Trial. J Maxillofac Oral Surg. 2024 Oct;23(5):1240-1247. doi: 10.1007/s12663-022-01831-1. Epub 2022 Dec 20.

  PMID: 39376771 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Vivek Kr Mahato, BDS

  B.P. Koirala Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate resident in Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 27, 2018
• Study Start: March 28, 2018
• Primary Completion: December 27, 2018
• Study Completion: March 27, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)